Quality Assurance Supervisor

7 days ago

San Antonio PR, United States Copan Industries Full time $80,000 - $120,000 per year

Overview

We are seeking a dedicated and detail-oriented Quality Assurance Supervisor to join our team. This role is essential in ensuring that our products meet the highest standards of quality and compliance with industry regulations. The ideal candidate will have a strong background in quality management systems, including ISO 13485, FDA regulations, and CGMP, as well as experience in manufacturing environments. As a Quality Assurance Supervisor, you will lead quality audits, oversee quality control processes, and ensure adherence to established quality systems.

Responsibilities

  • Supervise and manage the quality assurance team to ensure compliance with ISO 13485, FDA regulations, HACCP, CGMP, and ISO 9001 standards.
  • Conduct regular quality audits and inspections to assess compliance with internal and external standards.
  • Develop and implement quality control procedures to monitor product quality throughout the manufacturing process.
  • Collaborate with cross-functional teams to identify areas for improvement in quality management practices.
  • Analyze data from quality inspections and audits to identify trends and develop corrective actions.
  • Maintain documentation related to quality assurance activities, including reports on findings and recommendations.
  • Train and mentor team members on best practices in quality assurance and control methodologies.
  • Lead projects related to the enhancement of quality systems and processes.

Requirements

  • Bachelor's degree in a relevant field (e.g., Quality Management, Engineering, Life Sciences).
  • Review, evaluate and manage NC.
  • Oversee investigation and ensure trends of customer complaints
  • Lead the CAPA process
  • Attain supplier audits scheduled for next year 2026 and conduct supplier audits
  • Manage and/or support internal audits
  • Analyze quality data (NC, CAPA, Complaints)
  • Experience on Notified Body and/or Customer Audits
  • Proficiency in root cause analysis
  • Understanding of ISO13485 and 21 CFR 820Proven experience in a Quality Assurance role within a manufacturing environment.
  • Exceptional communication skills for collaboration across departments.
  • Ability to work independently as well as part of a team in a fast-paced environment. Join us in our commitment to excellence in product quality and safety

Job Type: Full-time

Benefits:

  • 401(k)
  • 401(k) matching
  • Dental insurance
  • Health insurance
  • Paid time off
  • Vision insurance

Work Location: In person

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